A biologics manufacturing organization is seeking a Senior Director of Manufacturing to lead large-scale mammalian cell culture operations (mAbs) across clinical and commercial programs.
If you want to know about the requirements for this role, read on for all the relevant information.
This is a highly visible leadership role responsible for end‑to‑end cGMP manufacturing, regulatory readiness, and operational performance at a rapidly expanding site. The role requires a hands‑on, execution-focused leader who can operate at both the strategic and operational level, partnering closely with senior leadership and cross‑functional teams.
Key Responsibilities
Lead and oversee cGMP manufacturing operations for biologic drug substance (mAbs) across clinical and commercial stages
Manage and develop a large‑scale manufacturing organization (~200+ FTEs)
Drive site performance, scalability, and operational excellence during a period of expansion
Partner closely with Quality and senior leadership to ensure inspection readiness and compliance
Play a key role in regulatory inspections (FDA and others), including direct involvement during audits
Support manufacturing contributions to IND/BLA filings (preferred)
Act as a primary point of contact for clients during site visits and manufacturing discussions
Implement and drive continuous improvement and LEAN manufacturing systems
Lead organizational growth, including team scaling, structure, and talent development
Required Qualifications
Extensive experience in biologic drug substance manufacturing (protein experience strongly preferred)
Background in mammalian cell culture manufacturing
Proven leadership of large, complex manufacturing teams (100+)
Strong experience in clinical and commercial manufacturing environments
Demonstrated involvement in regulatory inspections and compliance readiness
Experience in CDMO or similarly fast‑paced manufacturing environments strongly preferred xlxgzvr
Track record of driving operational improvements, scalability, and performance outcomes
Additional Information
Onsite role, 5 days/week
Standard travel expectations, including client‑facing responsibilities
Role is part of an expanded leadership structure at a growing manufacturing site
Target Candidate Profile
Experience in biologics manufacturing at scale (CDMO experience highly preferred)
Background leading organizations through growth, scale‑up, and regulatory milestones
Demonstrated success in building high‑performing teams in complex environments
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